ДСТУ EN 60601-1-2:2017 Вироби медичні електричні. Частина 1-2. Загальні вимоги щодо безпеки та основних робочих характеристик. Додатковий стандарт. Електромагнітна сумісність. Вимоги та випробування (EN 60601...

ПІДТВЕРДЖУВАЛЬНЕ ПОВІДОМЛЕННЯ

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Наказ від 26.12.2017 № 468

EN 60601-1-2:2015

Medical electrical equipment — Part 1-2: General requirements
for basic safety and essential performance — Collateral Standard:
Electromagnetic disturbances — Requirements and tests
(IEС 60601-1-2:2014)

прийнято як національний стандарт
методом «підтвердження» за позначенням
 

ДСТУ EN 60601-1-2:2017
(EN 60601-1-2:2015, IDT; IEС 60601-1-2:2014, IDT)

Вироби медичні електричні. Частина 1-2. Загальні вимоги
щодо безпеки та основних робочих характеристик. Додатковий стандарт.
Електромагнітна сумісність. Вимоги та випробування

З наданням чинності від 2018–02–01

Contents

European foreword

Annex ZA (normative) Normative references to international publications with their corresponding European publications

Annex ZZ (informative) Coverage of Essential Requirements of EU Directives

Foreword

Introduction

1 Scope, object and related standards

1.1 * Scope

1.2 Object

1.3 Related standards

1.3.1 IEC 60601-1

1.3.2 Particular standards

2 Normative references

3 Terms and definitions

4 General requirements

4.1 Risk management process for ME EQUIPMENT and ME SYSTEMS

4.2 * Non-ME EQUIPMENT used in an ME SYSTEM

4.3 General test conditions

4.3.1 * Configurations

4.3.2 Artificial hand

4.3.3 * Power input voltages and frequencies

5 ME EQUIPMENT and ME SYSTEMS identification, marking and documents

5.1 Additional requirements for marking on the outside of ME EQUIPMENT and ME SYSTEMS that are specified for use only in a shielded location SPECIAL ENVIRONMENT

5.2 ACCOMPANYING DOCUMENTS

5.2.1 Instructions for use

5.2.2 Technical description

6 Documentation of the tests

6.1 General

6.2 Test plan

6.3 Test report

7 ELECTROMAGNETIC EMISSIONS requirements for ME EQUIPMENT and ME SYSTEMS

7.1 Protection of radio services and other equipment

7.1.1 * General

7.1.2 Operating modes

7.1.3 Multimedia equipment

7.1.4 * Subsystems

7.1.5 ME EQUIPMENT and ME SYSTEMS specified for use only in a shielded location SPECIAL ENVIRONMENT

7.1.6 ME EQUIPMENT and ME SYSTEMS that include radio equipment

7.1.7 * ME EQUIPMENT whose main functions are performed by motors and switching or regulating devices

7.1.8 ME EQUIPMENT and ME SYSTEMS containing X-ray generators

7.1.9 PATIENT physiological simulation

7.1.10 Artificial hand

7.1.11 PATIENT-coupled cables

7.1.12 PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS

7.2 Protection of the PUBLIC MAINS NETWORK

7.2.1 * Harmonic distortion

7.2.2 * Voltage fluctuations and flicker

7.3 EMISSIONS requirements summary

8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS

8.1 * General

8.2 PATIENT physiological simulation

8.3 Termination of PATIENT-COUPLED parts

8.4 HAND-HELD ME EQUIPMENT and parts intended to be HAND-HELD

8.5 * Subsystems

8.6 PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS

8.7 * Operating modes

8.8 * Non-ME EQUIPMENT

8.9 * IMMUNITY TEST LEVELS

8.10 * IMMUNITY to proximity fields from RF wireless communications equipment

9 * Test report

Annex A (informative) General guidance and rationale

A.1 Safety and performance

A.2 Testing of normally non-observable functions

A.3 Rationale for particular clauses and subclauses

Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS

B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts

B.2 ACCOMPANYING DOCUMENTS, instructions for use

B.3 ACCOMPANYING DOCUMENTS, technical description

Annex C (informative) Guidance in classification according to CISPR 11

C.1 General

C.2 Separation into groups

C.3 Division into classes

Annex D (informative) Guidance in the application of IEC 60601-1-2 to particular standards

D.1  General

D.2  Recommended modifications

D.2.1  Testing requirements

D.2.2  ACCOMPANYING DOCUMENTS

D.3  Cautions

Annex E (informative)  Determination of IMMUNITY TEST LEVELS  for SPECIAL ENVIRONMENTS

E.1  General

E.2  Summary of method for E.1 a)

E.3  Summary of method for E.1 b), c) and d)

E.4  Determination of EM DISTURBANCE level reduction

E.5  Assessment of EM DISTURBANCE sources

E.6  Reasonably foreseeable maximum EM DISTURBANCE levels

E.7  Determination of IMMUNITY TEST LEVELS

E.8  RF radiators in SPECIAL ENVIRONMENTS

E.9  Examples of mitigations and special conditions

Annex F (informative)  RISK MANAGEMENT for BASIC SAFETY and ESSENTIAL PERFORMANCE  with regard to ELECTROMAGNETIC DISTURBANCES

F.1  General

F.2  General requirements for RISK MANAGEMENT

F.3  RISK ANALYSIS

F.4  RISK EVALUATION

F.5  RISK CONTROL

F.5.1  RISK CONTROL option analysis

F.5.2  Implementation of RISK CONTROL measure(s)

F.5.3  RESIDUAL RISK EVALUATION

F.5.4  RISK/benefit analysis

F.5.5  RISKS arising from RISK CONTROL measures

F.5.6  Completeness of RISK CONTROL

F.6  Evaluation of overall RESIDUAL RISK acceptability

F.7  RISK MANAGEMENT report

F.8  Production and post-production information

Annex G (informative)  Guidance: Test plan

G.1  Test plan contents

Annex H (informative)  PATIENT-coupled cables EMISSIONS

H.1  * Protection of other equipment from PATIENT cable conducted EMISSIONS

H.2  Test method

H.3  Rationale

Annex I (informative)  Identification of IMMUNITY pass/fail criteria

I.1  General

I.2  IMMUNITY pass/fail criteria principles

I.2.1  General

I.2.2  IMMUNITY pass/fail criteria for non-ME EQUIPMENT used in an ME SYSTEM

I.2.3  IMMUNITY pass/fail criteria determination

I.3  IMMUNITY pass/fail criteria examples

I.3.1  General examples

I.3.2  Example of IMMUNITY pass/fail criteria for a radiological table system

Bibliography

Index of defined terms used in this collateral standard